Process Development Sr. Engineer-Inspection Vision System

Juncos, PR, US
Oct 30, 2020
Required Education
Bachelors Degree
Position Type
Full time
Are you looking for a meaningful new opportunity to test and growth your technical skills? We have an immediate need for a Process Development Sr. Engineer - Inspection Vision System to join AML's Process Development Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.
The Role

Independently, the Process Development Sr. Engineer - Inspection Vision System will implement new, or continuously improve existing vision systems for the inspection of drug products, containers and devices, and for the character recognition of serialized variable data. Inspection systems throughout our operations are used to detect cosmetic defects on primary and secondary packaging, detect particles in solution, inspect for color and turbidity, detect label presence, inspection of fill volume and character recognition.

The candidate will develop a deep understanding of the operations and become a subject matter expert of the inspection process and current systems in place. Utilize the latest vision inspection tools and deep learning techniques to improve the performance of our current inspection processes. The role will provide support to new product introduction, improvement of existing processes and acquisition on new technologies. The position requires to have good documentation skills to write reports that can be used in regulatory audits.

Technical Responsibilities
  • Work in collaboration with three Drug product manufacturing plants to find opportunities to improve vision systems, increasing detectability rates of defects and reducing false reject rates.
  • Develop process solutions to a variety of technical problems of moderate scope and complexity enabling new equipment and technology
  • Responsible for ensuring that risks are identified, assessed and corrected to ensure the safety, purity, quality, and effectiveness of the product(s) manufactured and personnel
  • Ensure activities follow cGMP procedures and are documented according to cGMP requirements including assigned training
  • Independently evaluate, select and apply standard engineering techniques and procedures.
  • Perform assignments that have clear and specific objectives and require investigation of limited number of variables
  • Responsible for identifying, drive and lead continuous improvement opportunities and assist in prioritization of area project
  • Applies lean six sigma, operational excellence and continues improvement in assigned projects.

General responsibilities:
  • Available to support non-standard shift operations in a 7/24 format including extended hours and/or weekends as needed.
  • Meet specific project team goals and timelines.
  • Develop project plans and strategies for implementation working with project managers and SMEs.
  • Work in teams with multiple fields, including manufacturing, process engineering, maintenance, quality assurance, and validation to implement projects.
  • Communicates and/or presents scientific/ technical information within area of expertise across projects within a function/department, and occasionally to the external scientific community (i.e. regulatory agencies, review boards, conferences)
  • Supervise, coordinate and review work of a small team on a project basis.
  • May develop supervisory and mentoring skills.
  • Contributes to and may author scientific/technical documents (i.e. posters, presentations, publications, regulatory marketing applications, patent applications, technical reports, investigation reports)
  • May represent the department on project teams under supervision of a senior scientific staff member.
  • May initiate productive collaborations within and outside of the department or company.
Basic education & experience
Doctorate degree


Master's degree in Engineering and 3 years of experience in a GMP regulated industry.

Bachelor's degree in Engineering and 5 years of experience in a GMP regulated industry.

Preferred qualifications

Technical Skills
  • Knowledge of vision systems (Cognex, Systech, Optel, Keyence, EISAI, Seidenader, Brevetti, MvTech)
  • Knowledge on analog and digital cameras technology
  • Knowledge on illumination, lenses and frame grabbers settings
  • Knowledge in Artificial Intelligence and Deep Learning
  • Knowledge on PLC controls programming (Rockwell Automation / Allen Bradley (SLC500, PLC5, Micrologix, Compact Logix and Control Logix), Siemens Simatic/TIA, B&R)
  • Programming languages (Microsoft Visual Basic, .Net, Visual C#, Python, jscript, vbscript)
  • Industry standards for software development life cycle methodologies, 21 CFR Part 11, and GAMP
  • Tech Transfer, Process Design, Commissioning & Qualification
  • Design, installation and validation of automated processes (URS, SDS, HDS, P&IDs, FS, IQ, OQ, VSR, SOP's)
General Skills
  • Excellent communication skills: oral and written. Interacts effectively with variety of communication and working styles.
  • Fully bilingual in Spanish and English
  • Demonstrated strong problem solving and conflict resolution
  • Demonstrated leadership skills, initiative and self-motivation.
  • Excellent time and project management skills to deliver projects on time and budget.
  • Great teammate with strong negotiation skills to work with multidisciplinary teams that relies on collaboration for effective decision-making
  • High quality and compliance mind set to work in a highly regulated GMP industry.
  • Computer literacy (Windows environment: Word, Excel, Power Point, Minitab
The Benefits

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us passionate about your well-being too.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.